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CompletedNCT03465644TAILORED-CHIPUpdated Jun 6, 2025

TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI

A Phase 4 interventional study of Tailored antithrombotic strategy and Conventional antithrombotic strategy in Coronary Stenoses, sponsored by Duk-Woo Park, MD. Completed at 22 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by Duk-Woo Park, MD · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
2,018
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (\<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex PCI as compared with standard Dual Antiplatelet Therapy(aspirin and clopidogrel for 12 months).

02

Conditions studied

  • Coronary Stenoses

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Keywords

  • antithrombotic strategy
  • dual antiplatelet therapy
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 19 and more
  2. Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
  3. Patients must have at least one of any features of complex high-risk anatomic, procedural, or clinical-related factors;

    • Clinical factors: diabetes, chronic kidney disease (i.e. creatinine clearance \<60 mL/min), or low left ventricular ejection fraction (\<40%) or
    • Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two-stent technique, severe calcification, diffuse long lesion (lesion length ≥ at least 30 mm), multi-vessel PCI (≥ 2 vessels requiring stent implantation), ≥3 requiring stent implantation, ≥ 3 lesions will be treated, or predicted total stent length for revascularization > 60 mm
  4. The patient or guardian agreed to the study protocol and the schedule of clinical follow-up and provided informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.

Exclusion criteria

Exclusion Criteria:

  1. Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))
  2. Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
  3. Use of Gp IIb/IIIa inhibitors at randomization
  4. Cardiogenic shock
  5. Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.
  6. Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))
  7. Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)
  8. History of intracranial hemorrhage or intracranial aneurysm
  9. Planned surgery within 180 days
  10. Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening
  11. Platelet count \<80,000 cells/mm3 or hemoglobin level \<10 g/dL
  12. At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)
  13. Use of strong cytochrome P-450 3A inhibitor or inducers within 2 week of the date of enrollment

    : ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, rifampin/rifampicin, rifabutin, dexamethasone, phenytoin, carbamazepine, phenobarbital

  14. Pregnant and/or lactating women.
  15. Concurrent medical condition with a life expectancy of less than 1 years
  16. Active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period
  17. Inability to provide written informed consent or participate in long-term follow-up
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,018 participants (actual)

Study arms

  • Experimental
    Tailored arm

    early (\<6-month post-PCI) intensified (low-dose ticagrelor \[120 mg loading, then 60 mg bid maintenance\] and aspirin) and late (\>6-month post-PCI) deescalated (clopidogrel alone) strategy

    Drug: Tailored antithrombotic strategy

  • Active comparator
    Conventional arm

    clopidogrel + aspirin for 12months

    Drug: Conventional antithrombotic strategy

Interventions

  • DrugTailored antithrombotic strategy

    Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months

  • DrugConventional antithrombotic strategy

    Clopidogrel + aspirin for 12months

05

What researchers measure

Primary outcomes

  1. Net clinical outcome

    a net clinical outcome of all-cause death, myocardial infarction, stroke, stent thrombosis, urgent revascularization or clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\] at 12 months after randomisation

    Time frame: 1 year

Secondary outcomes

  1. Death

    Efficacy outcomes: any, cardiovascular, or non-cardiovascular cause death

    Time frame: 1 year

  2. Myocardial infarction

    Efficacy outcomes: any, periprocedural, or spontaneous Myocardial infarction

    Time frame: 1 year

  3. Stroke

    Efficacy outcomes: any, ischemic, or hemorrhagic Stroke

    Time frame: 1 year

  4. Stent thrombosis

    Efficacy outcomes

    Time frame: 1 year

  5. The rate of unplanned urgent repeat revascularization

    Efficacy outcomes: any, target-vessel, or non-target-vessel Repeat revascularisation

    Time frame: 1 year

  6. Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization)

    Efficacy outcomes

    Time frame: 1 year

  7. Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke)

    Efficacy outcomes

    Time frame: 1 year

  8. BARC major bleeding (type 3 or 5 bleeding)

    Safety outcomes: Bleeding Academic Research Consortium

    Time frame: 1 year

  9. TIMI major or minor bleeding

    Safety outcomes: Thrombolysis In Myocardial Infarction

    Time frame: 1 year

  10. GUSTO moderate or severe bleeding

    Safety outcomes: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries

    Time frame: 1 year

  11. ISTH major bleeding

    Safety outcomes: International Society of Thrombosis and Hemostasis; PCI, percutaneous coronary intervention

    Time frame: 1 year

  12. Any major or minor bleeding

    Safety outcomes

    Time frame: 1 year

06

Study locations

22 sites
  • Hallym University Sacred Heart Hospital
    Anyang, Korea, Republic of
  • Soon Chun Hyang University Hospital Bucheon
    Bucheon, Korea, Republic of
  • Gyeongsang National University Changwon Hospital
    Changwon, Korea, Republic of
  • Chungbuk National University Hospital
    Cheonju, Korea, Republic of
  • Gangwon National Univ. Hospital
    Chuncheon, Korea, Republic of
  • Daegu Catholic University Medical Center
    Daegu, Korea, Republic of
  • Keimyung University Dongsan Medical Center
    Daegu, Korea, Republic of
  • Gangneung Asan Hospital
    Gangneung, Korea, Republic of
  • Chonnam National University Hospital
    Gwangju, Korea, Republic of
  • Dong-A Medical Center
    Pusan, Korea, Republic of
  • Inje University Pusan Paik Hospital
    Pusan, Korea, Republic of
  • Pusan National University Hospital
    Pusan, Korea, Republic of
  • Seoul university Bundang hospital
    Seongnam-si, Korea, Republic of
  • Bundang CHA Hospital
    Seongnam, Korea, Republic of
  • Asan Medical Center
    Seoul, Korea, Republic of
  • Chung-Ang University Hospital
    Seoul, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
  • The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
    Seoul, Korea, Republic of
  • The Catholic University of Korea, Yeouido St. Mary's Hospital
    Seoul, Korea, Republic of
  • St.Carollo Hospital
    Suncheon, Korea, Republic of
  • The Catholic University of Korea, ST. Mary's Hospital
    Suwon, Korea, Republic of
  • Ulsan University Hospital
    Ulsan, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03465644
Lead sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Duk-Woo Park, MD (Professor, Division of Cardiology, Asan Medical Center) — Sponsor-investigator
First posted
Mar 14, 2018
Start date
Feb 12, 2019
Primary completion
Feb 13, 2025
Completion
Feb 13, 2025
Last update
Jun 6, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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